EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding.

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New and Revised FDA Import Alerts for Sept. 18

September 21, 2015 |FDA

On Sept. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA to Hold Workshop in Chicago on FSMA Preventative Controls Rules

September 21, 2015 |FDA

The Food and Drug Administration will hold a public meeting on Oct. 20 in Chicago to discuss its two recently-issued final rules on preventive controls for human and animal food (see 1509100021 and 1509100073), it said (here). “The public meeting will provide interested persons an opportunity to discuss the final rules for current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food and FDA’s comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act (FSMA) implementation,” said the agency. Registration is free, but seating is limited so preregistration (here) is encouraged, said FDA.

New and Revised FDA Import Alerts for Sept. 17

September 18, 2015 |FDA

On Sept. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Sept. 16

September 18, 2015 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Sept. 16

September 17, 2015 |FDA

On Sept. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Sept. 15

September 16, 2015 |FDA

On Sept. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Other Modified FDA Import Alerts for the Week of Sept. 7-13

September 15, 2015 |FDA

During the week of Sept. 7-13, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:

New and Revised FDA Import Alerts for Sept. 14

September 15, 2015 |FDA

On Sept. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Eliminates Export Option for Small Shipments of Illegal Prescription Drugs

September 15, 2015 |FDA

The Food and Drug Administration on Sept. 15 issued a final rule that makes it easier for the agency to destroy small shipments of illegal prescription drugs imported via international mail or express courier (here). The new regulations would allow FDA to destroy drug shipments valued at $2,500 or less that have been refused admission to the U.S., without giving the consignee the option of exporting the drugs. FDA is still required to give notice to the owner or consignee and the opportunity to request a hearing. The final rule takes effect Oct. 15.

New and Revised FDA Import Alerts for Sept. 11

September 14, 2015 |FDA

On Sept. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: